search
Back to results

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

Primary Purpose

Hypothyroidism

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Quantitative POC TSH Kit
Qualitative POC TSH Kit
Third generation TSH Kit
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypothyroidism focused on measuring Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspected hypothyroidism subject
  • Willing to comply with the trial protocol
  • Signed informed consent document

Exclusion Criteria:

  • Menstrual period, bleeding hemorrhoids, hematuria
  • Drinking or taking aspirin within 48 hours
  • Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
  • Subjects who are unwilling or unable to complete the trial
  • Subjects who do not sign informed consent form

Sites / Locations

  • Research site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

POC TSH Kits + Third Generation TSH Kit

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Positive and Negative TSH Test Result
Concentration of TSH in Whole Blood

Secondary Outcome Measures

Full Information

First Posted
August 9, 2013
Last Updated
November 20, 2014
Sponsor
Merck KGaA, Darmstadt, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01921452
Brief Title
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
Official Title
A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
Keywords
Hypothyroidism, Third generation TSH kit, Quantitative POC TSH kit, Qualitative POC TSH kit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POC TSH Kits + Third Generation TSH Kit
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Quantitative POC TSH Kit
Intervention Description
A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.
Intervention Type
Device
Intervention Name(s)
Qualitative POC TSH Kit
Intervention Description
A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.
Intervention Type
Device
Intervention Name(s)
Third generation TSH Kit
Intervention Description
One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.
Primary Outcome Measure Information:
Title
Number of Participants With Positive and Negative TSH Test Result
Time Frame
Day 1 up to Day 5
Title
Concentration of TSH in Whole Blood
Time Frame
Day 1 up to Day 5

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected hypothyroidism subject Willing to comply with the trial protocol Signed informed consent document Exclusion Criteria: Menstrual period, bleeding hemorrhoids, hematuria Drinking or taking aspirin within 48 hours Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability. Subjects who are unwilling or unable to complete the trial Subjects who do not sign informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Serono Co. Ltd. an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27605368
Citation
Wang T, Sheng S, Ruan M, Yan J, Gu J, Jiang Y, Gao Y, Lu H. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther. 2016 Nov;33(11):2001-2011. doi: 10.1007/s12325-016-0401-y. Epub 2016 Sep 7.
Results Reference
derived

Learn more about this trial

Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

We'll reach out to this number within 24 hrs